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Open Access Research

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design

Neela D Goswami1*, Ephraim L Tsalik28, Susanna Naggie23, William C Miller4, John R Horton5, Christopher D Pfeiffer67 and Charles B Hicks2

Author Affiliations

1 Department of Epidemiology, Rollins School of Public Health, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA

2 Department of Medicine, Duke University Medical Center, Durham, NC, USA

3 Duke Clinical Research Institute, Durham, NC, USA

4 Department of Epidemiology, Gillings School of Public Health, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA

5 GlaxoSmithKline Health Care, Parsippany, NJ, USA

6 Department of Hospital and Specialty Medicine, Portland VA Medical Center, Portland, OR, USA

7 Division of Infectious Diseases, Oregon Health and Science University, Portland, OR, USA

8 Research Service, Durham VAMC, 27710 Durham, NC, USA

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Trials 2014, 15:31  doi:10.1186/1745-6215-15-31

Published: 22 January 2014

Abstract

Background

The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves.

Methods

We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition.

Results

The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials.

Conclusions

No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.

Keywords:
Industry; Pharmaceutical; Bias; Randomization; Methodology; Trial